Resorbable crosslinked form stable membrane for use outside the oral cavity

Abstract

The invention relates to resorbable crosslinked form stable membrane which comprises a composite layer of collagen material and inorganic ceramic particles containing 1.5 to 3.5 weight parts of inorganic ceramic for 1 weight part of collagen material, sandwiched between two layers of elastic pretensed collagen material (collagen material that has been stretched such as to be in the linear / elastic region of the stress-strain curve), the collagen material comprising 50-100% (w / w) collagen and 0-50% (w / w) elastin, and has shape and dimensions suitable for use in human tissue regeneration outside the oral cavity in rhinoplasty, postlateral spinal fusion or orbital reconstruction.

Description

CROSS REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of European Patent Application No. 17174189 filed on Jun. 2, 2017, the disclosure of which is incorporated herein in its entirety by reference.FIELD OF THE INVENTION[0002]The invention relates to a resorbable crosslinked form stable composition for use in human tissue regeneration outside the oral cavity, notably in the craniofacial region and the cervical, thoracic, lumbar or sacral region of the spine, or in craniotomy reconstructive surgeries.BACKGROUND OF THE INVENTION[0003]In order to regenerate non-containing bony defects by bone formation, such as e.g. in horizontal or vertical augmentations in the maxilla or mandible, mechanical stabilization of the defect is required (Bendkowski 2005 Space to Grow in The Dentist, Merli et al. 2007 Vertical ridge augmentation with autogenous bone grafts: resorbable barriers supported by ostheosynthesis plates versus titanium-reinforced barriers. A preliminary rep...

AI Technical Summary

Benefits of technology

The invention is a membrane that can be used in rhinoplasty, posterolateral fusion, and orbital fracture reconstruction. The membrane has several advantages over traditional methods such as bone, cartilage, or skin. It is unlimited in availability, reduces surgery time, and has more flexibility in shape. The membrane can be filled with the material of choice and is mechanically stable, allowing for bone formation. It can be fixed using screws, pins, or scissors. The membrane is designed to become ossified and resorbed or osseo-integrated over time, and it has radio-opacity, allowing for control of implant position by computed tomography. Overall, the membrane provides a better solution for reconstructive surgery procedures.

Problems solved by technology

Indeed, oral tissues are exposed to complex mechanical forces during mastication, swallowing, tongue movement, speech, tooth movement and orthodontic treatment.

Especially during wound healing following surgical procedures, internal and external forces may occur, creating pressure, shear forces and bending moments upon the regenerative device and newly formed tissue.

However, the occurrence of dehiscences or other complications when using expanded Ti-reinforced membranes is reported to be high (Strietzel 2001 Risks and complications of membrane—guided bone regeneration.

The disadvantage of those membranes is that during their in vivo hydrolytic degradation they release lactic and / or glycolic acid which cause tissue irritation and histological signs of a disturbed wound healing (Coonts et al.

Autologous bone blocks have the disadvantage that they are harvested from a second site leading to more pain.

Disadvantages of this procedure are that it is extremely technique sensitive and that it is associated with second site morbidity and more pain.

Further, bone shields are applied only laterally, therefore no mechanical protection is given from the coronal aspect of the defect.

The disadvantages of this demineralized bone shield are that bent bone shields have to be fixed always, that they are relatively thick compared to e.g. Ti-reinforced PTFE membranes and that they come only in round shapes with curved edges on the coronal aspect of the bony defect.

However, that commercial membrane has weak form stability and a thickness of about 1.5 mm rising after incubation in saline to around about 2.3 mm; this may lead to a risk of a high dehiscence rate.

In summary the current solutions are thus not fully satisfying for dentists or patients.

Either a second surgery is necessary and / or there is a high risk of eventful wound healing.

Solutions which are not associated with a high risk of eventful wound healing are either not form stable membranes, require a second surgery or have other disadvantages.

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